ImmunizationsMCSkippNCT01224301
School Influenza Vaccine vs Standard of Care With Nested Trial of 2 Parent Notification Intensities
A study testing School based flu vaccine: Low intensity and School based flu vaccine: High intensity in people with Immunizations and Vaccination, run by Monroe County Department of Public Health at 1 site in United States.
Trial summary
Purpose of the study. The purpose of the project is to evaluate the feasibility, acceptability, and cost effectiveness of providing influenza vaccine in schools to children in grades Kindergarten through 6th grade. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Immunizations, Vaccination, Influenza
- What is being tested?
- School based flu vaccine: Low intensity and School based flu vaccine: High intensity
- Type of treatment
- Vaccines, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25,366 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children in grades K through 5 enrolled in schools that agreed to participate in the randomized trial of school based influenza vaccine
Who cannot join
- Children and schools not enrolled in school based influenza vaccine program Children in participating schools in grades other than Kindergarten through 5th grade.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe County Department of Public Health
Rochester, New York, 14692
About this study
Official title: Monroe COunty School Kids Influenza Prevention Project
Purpose of the study. The purpose of the project is to evaluate the feasibility, acceptability, and cost effectiveness of providing influenza vaccine in schools to children in grades Kindergarten through 6th grade.
Hypothesis 1: School based influenza vaccination (SIV) will increase the overall rate of influenza vaccination in school children.
Hypothesis 2: Higher intensity parent notification about school based influenza vaccination does not increase immunization rates compared to low intensity.
Hypothesis 3: School based vaccination from the perspective of mass vaccinators is cost neutral.
Read the detailed description
Background. The ACIP (American Committee on Immunization Practices) has now recommended influenza vaccination for all children 6 months to 18 years of age. While many school-aged children will be vaccinated in the medical home, the large number of children for whom the vaccine is now recommended exceeds the capacity of many primary care settings. Schools have been recommended as potential sites for influenza vaccination, yet little is known about the feasibility, implementation requirements, costs, or effectiveness of school-based influenza vaccination (SIV) programs. This project will implement and rigorously evaluate the feasibility, acceptability, billing and reimbursement components, costs, cost-effectiveness, and overall effectiveness of an SIV program that targets diverse populations and different intensity of interventions.
- Conditions
- Immunizations, Vaccination, Influenza, School Health
- Being tested
- School based flu vaccine: Low intensity, School based flu vaccine: High intensity
- Keywords
- seasonal influenza vaccine, school-based clinics, economic analysis of school based influenza vaccine delivery, pediatric influenza vaccine rates, Influenza vaccine information for parents
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School based flu vaccine: Low intensityBehavioural
Also called Trivalent injectable influenza vaccine, Live Attenuated Influenza vaccine, School based vaccines
Interventions: Parents of children in Low Intensity Notification schools got less than 3 communications from schools describing influenza vaccine and the clinics, and consent forms sent home one.
School based flu vaccine: High intensityBehavioural
Also called Trivalent injectable influenza vaccine, Live Attenuated Influenza vaccine, School based vaccines
Interventions: Parents in high intensity schools have 3 or more communications from schools about influenza illness, influenza vaccine, and school based clinics.
| Study group | Role | What they receive |
|---|---|---|
| School based flu vaccine: High intensity | Experimental | Interventions: Parents in high intensity schools have access to school-based flu vaccine clinics and 3 or more communications from schools about influenza illness, influenza vaccine, and school based clinics. Receives: Behavioral: School based flu vaccine: High intensity |
| School based flu vaccine: Low intensity | Experimental | Interventions: Parents in low intensity schools have access to school-based flu vaccine clinics and less than 3 communications from schools about influenza illness, influenza vaccine, and school based clinics. Receives: Behavioral: School based flu vaccine: Low intensity |
| Standard of Care | No intervention | Control Schools did not have any in school seasonal influenza vaccine clinics. Parents of children in control schools got no notification from the schools and sought seasonal influenza vaccines for their children as they normally would. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seasonal influenza vaccine rates for children attending schools with and without school-based influenza vaccine delivery as reported in the New York State Immunization Information System (NYSIIS).
Number of children with at least one seasonal influenza vaccine given in school compared to number of children with influenza vaccine given elsewhere and number of children with no record of influenza vaccine.
Measured: Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010
Seasonal influenza vaccine rates for children attending schools with and without school-based influenza vaccine delivery as reported in the New York State Immunization Information System (NYSIIS).
Number of children with at least one seasonal influenza vaccine given in school compared to number of children with influenza vaccine given elsewhere and number of children with no record of influenza vaccine.
Measured: Year 2: Influenza vaccine delivery season: August 1, 2010 to January 15, 2011
Secondary outcomes (3)
Number of seasonal influenza vaccines received by children enrolled in schools with high vs. low vs. no parental notification.
Vaccine rates among children offered seasonal influenza vaccine in school whose parents got high intensity notification of the program vs those who got low intensity notification. Notification included educational materials, program description, consent forms, phone messages, and varied by type and frequency for schools with High and Low levels of parental notification.
Measured: Year 1 Influenza vaccine delivery season: August 15, 2009 to January 15, 2010
Number of seasonal influenza vaccines received by children enrolled in schools with high vs low vs no parental notification.
Vaccine rates among children offered seasonal influenza vaccine in school whose parents got high intensity notification of the program vs those who got low intensity notification. Notification included educational materials, program description, consent forms, phone messages, and varied by type and frequency for schools with High and Low levels of parental notification.
Measured: Year 2: Influenza vaccine delivery season: August 1, 2010 to January 15, 2011
Costs and incremental cost effectiveness of seasonal influenza vaccines delivered in schools compared to cost of influenza vaccines delivered in private practice.
Economic analysis of costs and revenues associated with school-based seasonal influenza vaccine delivered by a mass vaccinator. The project is based on a business model for purchasing/acquiring vaccine from vendors and vaccines for children, and recovering payment from insurance. Costs associated with vaccines administered in school are derived from this clinical trial, School Influenza Vaccine vs Standard of Care, and private practice data are from the literature.
Measured: Time Frame: (FDAAA) Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startSep 2009
- Primary completionOct 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImmunizationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 25,366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monroe County Department of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester
- Responsible party
- Principal investigator, Sharon G. Humiston, M.D., M.P.H., University of Rochester
- Investigators
- Sharon G. Humiston, M.D., M.P.H., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224301
- Sponsor's protocol ID
- 00439262
- Acronym
- MCSkipp
- Status last verified
- Apr 2012
- First submitted
- 18 Oct 2010
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Humiston SG, Schaffer SJ, Szilagyi PG, Long CE, Chappel TR, Blumkin AK, Szydlowski J, Kolasa MS. Seasonal influenza vaccination at school: a randomized controlled trial. Am J Prev Med. 2014 Jan;46(1):1-9. doi: 10.1016/j.amepre.2013.08.021.
PubMed 24355665
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monroe COunty School Kids Influenza Prevention Project
- ClinicalTrials.gov ID
- NCT01224301
- Acronym / sponsor ID
- MCSkipp / 00439262
- Conditions
- Immunizations, Vaccination, Influenza, School Health
- Keywords
- seasonal influenza vaccine, school-based clinics, economic analysis of school based influenza vaccine delivery, pediatric influenza vaccine rates, Influenza vaccine information for parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25,366 participants (actual)
- Lead sponsor
- Monroe County Department of Public HealthUniversity, hospital or other
- Collaborators
- University of Rochester
- Study start
- Sep 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of the study. The purpose of the project is to evaluate the feasibility, acceptability, and cost effectiveness of providing influenza vaccine in schools to children in grades Kindergarten through 6th grade.
Hypothesis 1: School based influenza vaccination (SIV) will increase the overall rate of influenza vaccination in school children.
Hypothesis 2: Higher intensity parent notification about school based influenza vaccination does not increase immunization rates compared to low intensity.
Hypothesis 3: School based vaccination from the perspective of mass vaccinators is cost neutral.
Detailed description
Background. The ACIP (American Committee on Immunization Practices) has now recommended influenza vaccination for all children 6 months to 18 years of age. While many school-aged children will be vaccinated in the medical home, the large number of children for whom the vaccine is now recommended exceeds the capacity of many primary care settings. Schools have been recommended as potential sites for influenza vaccination, yet little is known about the feasibility, implementation requirements, costs, or effectiveness of school-based influenza vaccination (SIV) programs. This project will implement and rigorously evaluate the feasibility, acceptability, billing and reimbursement components, costs, cost-effectiveness, and overall effectiveness of an SIV program that targets diverse populations and different intensity of interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| School based flu vaccine: High intensity | Experimental | Behavioral: School based flu vaccine: High intensityInterventions: Parents in high intensity schools have access to school-based flu vaccine clinics and 3 or more communications from schools about influenza illness, influenza vaccine, and school based clinics. |
| School based flu vaccine: Low intensity | Experimental | Behavioral: School based flu vaccine: Low intensityInterventions: Parents in low intensity schools have access to school-based flu vaccine clinics and less than 3 communications from schools about influenza illness, influenza vaccine, and school based clinics. |
| Standard of Care | No intervention | –Control Schools did not have any in school seasonal influenza vaccine clinics. Parents of children in control schools got no notification from the schools and sought seasonal influenza vaccines for their children as they normally would. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children in grades K through 5 enrolled in schools that agreed to participate in the randomized trial of school based influenza vaccine
Key exclusion criteria (2 listed)
- Children and schools not enrolled in school based influenza vaccine program Children in participating schools in grades other than Kindergarten through 5th grade.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School based flu vaccine: Low intensityAlso: Trivalent injectable influenza vaccine, Live Attenuated Influenza vaccine, School based vaccinesInterventions: Parents of children in Low Intensity Notification schools got less than 3 communications from schools describing influenza vaccine and the clinics, and consent forms sent home one. | Behavioural | School based flu vaccine: Low intensity |
| School based flu vaccine: High intensityAlso: Trivalent injectable influenza vaccine, Live Attenuated Influenza vaccine, School based vaccinesInterventions: Parents in high intensity schools have 3 or more communications from schools about influenza illness, influenza vaccine, and school based clinics. | Behavioural | School based flu vaccine: High intensity |
Primary outcome
Seasonal influenza vaccine rates for children attending schools with and without school-based influenza vaccine delivery as reported in the New York State Immunization Information System (NYSIIS).
Time frame: Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010
Number of children with at least one seasonal influenza vaccine given in school compared to number of children with influenza vaccine given elsewhere and number of children with no record of influenza vaccine.
Seasonal influenza vaccine rates for children attending schools with and without school-based influenza vaccine delivery as reported in the New York State Immunization Information System (NYSIIS).
Time frame: Year 2: Influenza vaccine delivery season: August 1, 2010 to January 15, 2011
Number of children with at least one seasonal influenza vaccine given in school compared to number of children with influenza vaccine given elsewhere and number of children with no record of influenza vaccine.
3 secondary outcomes
Number of seasonal influenza vaccines received by children enrolled in schools with high vs. low vs. no parental notification.
Time frame: Year 1 Influenza vaccine delivery season: August 15, 2009 to January 15, 2010
Number of seasonal influenza vaccines received by children enrolled in schools with high vs low vs no parental notification.
Time frame: Year 2: Influenza vaccine delivery season: August 1, 2010 to January 15, 2011
Costs and incremental cost effectiveness of seasonal influenza vaccines delivered in schools compared to cost of influenza vaccines delivered in private practice.
Time frame: Time Frame: (FDAAA) Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2012.
- Derived from this study: PubMed 24355665Humiston SG, Schaffer SJ, Szilagyi PG, Long CE, Chappel TR, Blumkin AK, Szydlowski J, Kolasa MS. Seasonal influenza vaccination at school: a randomized controlled trial. Am J Prev Med. 2014 Jan;46(1):1-9. doi: 10.1016/j.amepre.2013.08.021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon G. Humiston, M.D., M.P.H. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School based flu vaccine: Low intensity and School based flu vaccine: High intensity in people with Immunizations and Vaccination, run by Monroe County Department of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seasonal influenza vaccine rates for children attending schools with and without school-based influenza vaccine delivery as reported in the New York State Immunization Information System (NYSIIS). (time frame: Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01224301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2012.